K832742 is an FDA 510(k) clearance for the EXTENSION CONTROL KNEE ORTHOSIS. This device is classified as a Cage, Knee (Class I - General Controls, product code ITM).
Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983, 36 days after receiving the submission on August 15, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K832742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1983 |
| Decision Date | September 20, 1983 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ITM — Cage, Knee |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |